Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not...
Greg Anderson
Like it or not, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is here. MACRA created the new Quality Payment Program, comprised of two pathways to higher quality: the Merit-Based...
Laura Gillenwater
I recently had the privilege of attending the Health Care Advisory Board’s National Meeting in St. Louis. One of the topics that really struck me was the last presentation about the importance of...
Anna Nagurney
When we talk about supply chains, we may conjure up images of manufacturing plants, warehouses, trucks, and shipping docks. There is another, truly unique supply chain for a product vitally...
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling...
Robert M. Califf
About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The...
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this...
Davis Balestracci
Those of you familiar with W. Edwards Deming know that his Funnel Experiment ultimately shows that a process in control delivers the best results if left alone. Funnel Rule No. 4, also known as a “...
Vijay Iyer
As the director of the structural heart team at Kaleida Health’s Gates Vascular Institute in Buffalo, New York, I perform minimally invasive, endovascular surgeries to repair structural defects of...
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes...
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to...
Joel Bradbury
Healthcare professionals have a long history of caring for their patients and improving the quality of their services. During the Crimean War (1853–1856), British nurse Florence Nightingale...
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a...
Brooke Pierce
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at...
Michael Causey
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part...
Theresa M. Mullin
Since the launch of the Patient-Focused Drug Development (PFDD) program as part of the fifth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) has...
Scott Rader
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-...
Kade Moody
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your...
Andrew Maynard
In 2014, more than 32,000 people were killed in car crashes in the United States. In 2012, more than 2 million Americans visited the emergency room as a result of car crashes. An estimated 94...
GBMP
Ellis Medicine is a 438-bed community and teaching healthcare system serving New York’s capital region. With four main campuses, five additional service locations, more than 3,300 employees,...
